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Sign in to claim this brandSentinel Ch. Srl
US
Last updated May 23, 2026
What Sentinel Ch. Srl makes
Sentinel Ch. Srl makes in vitro diagnostic (IVD) devices, including reagents, calibrators, and controls for measuring various substances such as angiotensin converting enzyme (ACE), kappa/lambda light chain immunoglobulin, ceruloplasmin, cystatin C, and albumin. They also produce laboratory instrument/analyser application software and kits for nephelometry/turbidimetry.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA's 510(k) and UDI registries. Sentinel Ch. Srl is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Sentinel Ch. Srl manufacture?
Sentinel Ch. Srl produces in vitro diagnostic (IVD) devices, including reagents, calibrators, and controls for measuring substances like angiotensin converting enzyme (ACE), kappa/lambda light chain immunoglobulin, ceruloplasmin, cystatin C, and albumin. They also make laboratory instrument software and nephelometry/turbidimetry kits.
Where is Sentinel Ch. Srl based?
Sentinel Ch. Srl is based in the United States, as indicated by the country information provided in the device data.
Which regulatory registries list Sentinel Ch. Srl's devices?
Sentinel Ch. Srl's devices are listed in the FDA's 510(k) and UDI (Unique Device Identification) registries, as specified in the device data.
How are Sentinel Ch. Srl's devices classified?
Sentinel Ch. Srl's devices are regulated under Class I and Class II classifications, as stated in the device data, which determines the level of regulatory control they undergo.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (64)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ACE Calibrator | 06U8601 | FDA UDI | Class II | Active |
| ACE Liquid | 1767001 | FDA UDI | Class II | Active |
| Lp(a) Ultra | 11504D | FDA UDI | Class II | Active |
| Alinity c ACE Assay File | 06U86-1A | FDA UDI | Class I | Active |
| ACE Calibrator | 06U8201 | FDA UDI | Class II | Active |
| ACE Control | 06U8210 | FDA UDI | Class I | Active |
| Lipase NG OC Reagent Kit | 04Y85-20 | FDA UDI | Class I | Active |
| Lipase Color Liquid | 17401B | FDA UDI | Class I | Active |
| Lambda light chains | A26849 | FDA UDI | Class II | Active |
| Lp(a) Control Set | 1152201 | FDA UDI | Class I | Active |
| Immuno Control Set | 11211A | FDA UDI | Class I | Active |
| Albumin BCP (6x20 mL) | C22855 | FDA UDI | Class II | Active |
| Kappa light chains | A26845 | FDA UDI | Class II | Active |
| Ckmb Udr | A53720 | FDA UDI | Class II | Active |
| ACE Control | 06U8610 | FDA UDI | Class I | Active |
| CRP Ultra (MP) | 115646 | FDA UDI | Class II | Active |
| Lipase NG OC Cal | 04Y85-01 | FDA UDI | Class II | Active |
| ACE Reagent | 06U8625 | FDA UDI | Class II | Active |
| Lipase NG OC CTRL 2 | 04Y85-11 | FDA UDI | Class I | Active |
| Cholinesterase Liquid | 17019H | FDA UDI | Class I | Active |
| Cystatin C | 06T3220 | FDA UDI | Class II | Active |
| Plasmaproteins Cal 3x | A26854 | FDA UDI | Class II | Active |
| Cystatin C Calibrators | 06T3201 | FDA UDI | Class II | Active |
| Pancreatic Amylase | A53704 | FDA UDI | Class II | Active |
| Cystatin C | 06T3230 | FDA UDI | Class II | Active |
| Cystatin C Controls | 06T3210 | FDA UDI | Class I | Active |
| Lipase NG Cal | B83544 | FDA UDI | Class II | Active |
| Clin Chem Control 2 | 16250 | FDA UDI | Class I | Active |
| Clin Chem Cal | 16550 | FDA UDI | Class II | Active |
| Lp(a) Cal Set | 11522D | FDA UDI | Class II | Active |
| Plasmaproteins Cal 3x | 11206D | FDA UDI | Class II | Active |
| Lipase NG | B82715 | FDA UDI | Class I | Active |
| ACE Control Set | 1667001 | FDA UDI | Class I | Active |
| ARCHITECT c ACE Assay File | 6U82-1A | FDA UDI | Class I | Active |
| ACE Calibrator | 1665001 | FDA UDI | Class II | Active |
| Clin Chem Control 1 | 16150 | FDA UDI | Class I | Active |
| alpha 1-Acid Glycoprotein | A26838 | FDA UDI | Class I | Active |
| ACE Reagent | 06U8225 | FDA UDI | Class II | Active |
| Lipase NG OC CTRL 1 | 04Y85-10 | FDA UDI | Class I | Active |
| Ceruloplasmin | 11065N | FDA UDI | Class II | Active |
| Ceruloplasmin | A26842 | FDA UDI | Class II | Active |
| Albumin BCP (6x50 mL) | C22856 | FDA UDI | Class II | Active |
| Multigent Creatinine (enzymatic) Assay | K073634 | FDA 510(k) | Class II | Active |
| CRP Vario | K192118 | FDA 510(k) | Class II | Active |
| Cystatin C | K242585 | FDA 510(k) | Class II | Active |
| Sentinel Plasmaproteins Cal 3x | K081533 | FDA 510(k) | Class II | Active |
| Ckmb Udr Assay | K102706 | FDA 510(k) | Class II | Active |
| Sentinel Uibc Liquid | K051111 | FDA 510(k) | Class I | Active |
| Sentinel Ammonia Ultra Diagnostic Assay | K051114 | FDA 510(k) | Class I | Active |
| Modification To Sentinel Clin Chem Cal | K070971 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sentinel Ch. Spa MILANO · IT FEI 3000303338